MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY TIBIAL TRAY SIZE 1 TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	33650001
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for evaluation as it remains implanted in the patient.If additional information becomes available, it will be provided on a supplemental report.Device remains implanted in patient.
Event or Problem Description
Previous total ankle replacement implanted.The patient has develop a medial malleolar stress fracture and the tibial implant has subsided and is now in a tilt.The patient needs to be revised to a invision revision implant and this is booked for early 2022.
Additional Manufacturer Narrative
The reported migration could be confirmed, since the ct-scan matches the alleged failure.The device inspection revealed the following: visual examination has shown that the implant has signs of explantation, as the locking mechanism to lock the poly in the tibial tray is badly damaged with signs of deformation and abrasion/chipping.Furthermore, it¿s visible that the plasma coating got damaged and came partially off, also visible yellow/gold shining discoloration/scratches which are most likely a result from explantation with a chisel.Medical profession reviewed the images and noted: the x-rays of (b)(6) 2021, show a well-aligned and properly sized tar implant with good restoration of the joint line at the original height.As far as i can see, the bone stock looks well and besides the two pinholes (with is sop with this tar), i see no radiographic abnormalities of the periprosthetic bone.The ct-scan are suggestive for some tilt of the talar component, nevertheless, its image quality is insufficient to state the presence of a stress fracture.There are many clinical factors that can affect the results of any surgery, such as surgical technique, pre-operative and post-operative care, the implant, patient pathology and daily activity.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
Previous total ankle replacement implanted.The patient has develop a medial malleolar stress fracture and the tibial implant has subsided and is now in a tilt.The patient needs to be revised to a invision revision implant and this is booked for early 2022.

• Brand Name: INFINITY TIBIAL TRAY SIZE 1 TOTAL ANKLE SYSTEM
• Common Device Name: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13019335
• Report Number: 3010667733-2021-00014
• Device Sequence Number: 11947494
• Product Code: HSN
• UDI-Device Identifier: 00840420122483
• UDI-Public: 00840420122483
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K140749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 33650001
• Device Catalogue Number: 33650001
• Device Lot Number: 1663280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2021
• Supplement Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 12/16/2021
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female